Identity
- Trade Name
- OneLIF™ FDA UDI
- Generic Name
- Spinal implant trial FDA UDI
- Device Name
- Starter Trial, Large, 13deg, 7mm AH - 2PH FDA UDI
- Model / Reference
- 011-713-0002 FDA UDI
- Description
- Starter Trial, Large, 13deg, 7mm AH - 2PH FDA UDI
Identifiers
- Catalog Number
- 011-713-0002 FDA UDI
- Primary DI / UDI-DI
- G07001171300020 FDA UDI
- 510(k) Number
- K211769 FDA UDI
- FDA Product Code
- OVD FDA UDIMAX FDA UDI
- GMDN Term
- Spinal implant trial FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3080 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Spinal implant trial
OneLIF™ by Novapproach Spine — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Spinal implant trial.
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- IdentiTi — ALPHATEC SPINE, INC. · Class II
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Cleared under the same submission
K211769 also covers:
- OneLIF™ — Novapproach Spine
- OneLIF™ — Novapproach Spine
- OneLIF™ — Novapproach Spine
- OneLIF™ — Novapproach Spine
- OneLIF™ — Novapproach Spine
- OneLIF™ — Novapproach Spine
- OneLIF™ — Novapproach Spine
- OneLIF™ — Novapproach Spine
- OneLIF™ — Novapproach Spine
- OneLIF™ — Novapproach Spine
- OneLIF™ — Novapproach Spine
- OneLIF™ — Novapproach Spine
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Novapproach Spine
Sources (1)
- FDA UDI d3394df2-909e-438c-9be5-599bfc1b4bdb 36 fields · synced May 30, 2026